The government said it has banned the imports of Zantac (ingredient: ranitidine), a stomach medicine supplied by GlaxoSmithKline Korea, for three months.
The Ministry of Food and Drug Safety on Thursday issued an administrative suspension order on GSK to stop importing 150-mg Zantac Tab. from March 20 to June 19 for violating Pharmaceutical Affairs Act.
Zantac was supposed to be white and rounded with films coated on both sides. However, the regulator discovered that some products distributed in the market were thicker than the others and that some parts of the coatings around the tablets slightly broke.
Some differences in shape rarely cause side effects, but changes in color, taste, and wrapping might hurt the safety and efficacy of the drug, directly affecting the quality of the product.
Zantac is sold in 75-mg dose as over-the-counter (OTC) drugs, and 150-mg as prescription medicines.
The OTC Zantac is used for excessive gastric acid, heartburn, and sour burp. The 150-mg Zantac is prescribed for acute gastritis, gastric ulcer, duodenal ulcer, and gastroesophageal reflux disease in children aged from 3 to 18.